BEUDAMED
    15 results · 24ms · Sources: EU EUDAMED, US FDA

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    Segment CMR

    FDA 510(k)
    FDA Class 2 ·Radiology

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 1, 2021

    DYNAFLEX

    FDA 510(k)
    FDA Class 2 ·Dental

    REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Widex

    FDA UDI
    Widex A/S·05706069819564·Widex UNIQUE U-FS (Sporty red ) 50, Telecoil, R...

    Widex

    FDA UDI
    Widex A/S·05706069792867·Widex UNIQUE U-PA (Sporty red ) 50, RC coil

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 15, 2011

    PCM CERVICAL DISC SYSTEM

    FDA Adverse Event
    Other ·NUVASIVE, INC.·Product code MJO·May 29, 2013

    ONE TOUCH ULTRAMINI METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·September 15, 2008

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 1, 2021

    TIBIAL INSERT FIXED SPHERE FLEX SIZE5/10 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 12, 2018

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 1, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 1, 2021

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·December 1, 2021

    RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014